Comparison Between Lorazepam, Clonazepam and Clonazepam + Fosphenytoin for the Treatment of Out-of-hospital Generalized Status Epilepticus

• Status: Completed
• Trial end date: 2018-02-23
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to know on one hand if lorazepam is more (effective) than clonazepam and on the other hand if lorazepam is also effective as the association clonazepam + fosphenytoin in out-of-hospital treatment of the generalized convulsive status epilepticus in adult patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Clonazepam; Fosphenytoin; Lorazepam; Phenytoin

Criteria

Inclusion Criteria:

• Patients aged 18 years or older

• Out-of-hospital management

• presenting one of the criteria below noticed by the physician of the mobile intensive care unit:

1. convulsive seizures at the time of treatment and were reported by reliable witnesses to have been continuously convulsing for longer than 5 minutes, without regaining consciousness, or

2. if they were having more than 2 repeated convulsive seizures at the time of treatment without regaining consciousness

Exclusion Criteria:

• Patient having been already included in the study during a previous episode of status epilepticus

• Patient having already received before the arrival of the mobile intensive care unit one of theses studied drugs (lorazepam, clonazepam or fosphenytoin or phenytoin)

• Latent status epilepticus in deep coma

• Cerebral anoxia (post cardio respiratory arrest)

• Severe head trauma

• Patient presenting convulsive seizures of psychogenic origin

• Lennox Gastaut's syndrome

• Decision of urgent intubation

• Patients of more than 110 kg ( estimated weight

• Heart rate < 60 bpm or > 150 bpm

• Systolic Blood Pressure < 90 mmHg

• Atrioventricular block of 2nd or 3rd degree

• Ventricular tachycardia or ventricular fibrillation

• Sensibility known about benzodiazepines, fosphenytoin, phenytoin, other hydantoins, or barbiturate

• Contraindication known about benzodiazepines (severe respiratory failure, severe acute hepatic failure, myasthenia, syndrome of sleep apnea, glaucoma with closed angle

• Contraindication known about fosphenytoin (intermittent acute porphyry)

• Contraindication known about barbiturate (porphyry, severe respiratory failure, current treatment by saquinavir, ifosfamide and voriconazole, in association with millepertuis)

• Person unaffiliated in a National Social Security Insurance

• Pregnant or breast-feeding Woman

• Impossibility to put an intravenous or intra-osseous catheter for the treatment injection

• Absence of nurse in the mobile intensive care unit.